FDA clears text

FX Solutions’ Shoulder Prosthesis Cleared

February 19, 2021

The FDA has granted 510(k) marketing clearance for FX Solutions’ Easytech Stemless Anatomic, a stemless shoulder prosthetic designed for total shoulder replacements.

The product is intended to treat severely painful or disabled shoulder joints with functional rotator cuffs that result from osteoarthritis. The prosthetic device comes in a range of anchor base diameters, from 30 to 42mm.

The design of the prosthetic’s anchor base allows it to fit inside the cortical bone for optimal fixation.

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